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510(k) Data Aggregation

    K Number
    K220761
    Device Name
    CIRCUL8 Connect DVT Prevention Device
    Manufacturer
    Ortho8, Inc.
    Date Cleared
    2022-06-03

    (80 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CIRCUL8 Connect DVT Prevention Device is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

    This device can be used to:

    • · Aid in the prevention of DVT:
    • · Enhance blood circulation;
    • · Diminish post-operative pain and swelling;
    • · Reduce wound healing time:
    • · Aid in the treatment and healing of; stasis dernatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

    The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer the request as there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the CIRCUL8 Connect DVT Prevention Device, which means the device has been found substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not contain information about performance studies or acceptance criteria for the device's efficacy.

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